CTRI/2022/04/041622尚未招募3 期
Effect of add on dapagliflozin versus standard-of-care on bone and mineral indices in postmenopausal women with type2 diabetes mellitus: a randomized controlled study
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Post-menopausal women ( duration of menopause > 5years ) and age < 65 years diagnosed with T2DM and being initiated on SGLT2i shall be enrolled into the study.
- •2.Patients on diet alone therapy or with other anti-diabetic agents (metformin, alpha-glucosidase inhibitors, DPP4i or insulin) may be used for achieving glycaemic targets.
- •3. HbA1C <10 %
- •4.Duration of DM > 5 years
排除标准
- •1. Current users of any of the SGLT2i (Cana or Dapa or Empa )
- •2.Patients on bone active agents (anti-resrorptives or osteoanabolics)
- •3.Patients on chronic glucocorticoid therapy ( >3 months)
- •4.Other drugs (thiazolidinediones, phenytoin, tamoxifen, estrogen, combined OCs)
- •5.eGFR <30ml/min/m2
- •6.Contraindication or hypersensitivity to SGLT2i
- •7.Patients with T1DM, FCPD or known case of secondary diabetes
- •8.Pregnant or lactating women
- •9.Premature ovarian insufficiency
- •10.HbA1C >10%
- •11.Known case and/or specific features of Cushingââ?¬•s, Addisonââ?¬•s, acromegaly, prolactinoma, uncontrolled hypothyroidism, hyperthyroidism, celiac disease, primary hyperparathyroidism
- •12.Those unwilling for consent to participate and follow-up
研究者
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